A Study of RO5093151 in Patients With Non-Alcoholic Fatty Liver Disease

Multi-center, Double-blind, Randomized, Placebo-controlled Study of Selective 11 Beta-HSD1 Inhibition With RO5093151 for 12 Weeks to Investigate Efficacy, Safety and Pharmacokinetics of RO5093151 in Non-alcoholic Fatty Liver Disease and Its Metabolic Consequences.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01277094

Enrollment

Registered

2011-01-14

Start date

2011-04-30

Completion date

2012-03-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatty Liver, Non-alcoholic Fatty Liver Disease, NAFLD

Brief summary

This multi-center, double-blind, randomized, placebo-controlled study will evaluate the change in liver fat content, pharmacokinetics and safety of RO5093151 in patients with non-alcoholic fatty liver disease. Patients will be randomized to receive either daily oral doses of RO5093151 or matching placebo. The anticipated time on study treatment is 12 weeks.

Interventions

DRUGPlacebo

Oral daily doses for 12 weeks

DRUGRO5093151

Oral daily doses for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

35 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Adult patients, 35-65 years of age * Hepatic steatosis assessed by magnetic resonance spectroscopy (MRS) with liver fat \>5.56% at screening * Body mass index (BMI) \>27 kg/m2 at screening * Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR) \> 2.5 at screening * Agreement to maintain prior diet and exercise habits during the full course of study

Exclusion criteria

* History of diabetes mellitus based on World Health Organization (WHO) criteria * Known polycystic ovary syndrome * Other liver disease e.g. chronic viral hepatitis, alcoholic liver disease, hemachromatosis, cirrhosis * Known autoimmune disease or chronic inflammatory disease * Myocardial infarction or stroke within 6 months prior to screening * Patients taking any anti-diabetic and/or weight-lowering medication currently or within the previous 3 months before screening

Design outcomes

Primary

Measure	Time frame
Change of liver fat content measured by magnetic resonance spectroscopy (MRS)	Week 12

Secondary

Measure	Time frame
Change in insulin resistance assessed by hyperinsulinemic euglycemic clamp	Week 12
Change in endogenous glucose production assessed by hyperinsulinemic euglycemic clamp	Week 12
Pharmacokinetic measures (max and min concentration, clearance, half-life, etc)	Week 12
Safety (incidence and nature of adverse events)	Week 12

Countries

Austria, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026